Course Overview

  • “Well planned. Professional tutors. It has been a pleasure. Good with the group works and the social arrangements.” Mie Weibel / PEC, Denmark
  • “It is a fun and relaxed way of knowing much more about GMP.”Elma Snijder / Solvay, Netherlands
  • “Up-to-date knowledge from (in) good presentations. Well built, easy to understand, good examples.” Tibor Erdös / Beckton Dickinson & Co, Hungary
  • “The standard of lecturers/presenters was excellent, very impressed with the quality and completeness of the material covered.” Gerrard Kemmy / Covidien, Republic of Ireland
  • “Superb, enjoyable and expertly delivered. Many thanks.”Doug Strachan / Emcor, UK
  • “Coming from another industry, this course was a really good overview of GMP.” Richard Griffiths / Bard Pharmaceuticals, UK
  • “Excellent structure, use of experience and engagement.” John Facer / 3M Healthcare, UK

Europe’s most popular GMP course! This intensive and highly interactive 3.5 day course is designed to teach you all you need to know about the latest EU requirements for Pharmaceutical GMP, so that you can go back to your workplace and put them into practice with your colleagues. Our GMP courses are known and respected all over the globe. Come and benefit from our experience!

Reigster

About This Course

It is a legal requirement that all staff receive training in pharmaceutical Good Manufacturing Practice (GMP) at induction and regularly thereafter.

Whether you’re just starting out in the industry or you’re an experienced member of staff changing roles to work in a GMP environment, this course will provide you with the fundamentals and latest updates regarding GMP.

This course covers key sections of the ever-changing EudraLex Volume 4 to provide a thorough understanding of the essentials of GMP.

Europe’s most popular Pharmaceutical GMP training course!

  • Tutors with real credibility and experience to bring GMP to life with examples and real life stories
  • Training designed to reach all learning styles and preferences
  • Fantastic detailed reference material to take away and to become instantly useful
  • Bring your questions and have the free consultancy of tapping into great experience from helpful tutors
  • This course repeatedly achieves the highest customer satisfaction level of any of our courses, with 95% of delegates rating it “very good” or “excellent”, have peace of mind that you’re in the best of hands
  • This course now forms an entry level GMP training requirement for our very popular Pharmaceutical Quality Systems Auditor/Lead Auditor Training Programme
  • An ideal starting point for our modular QP training program
     

Key Learning Objectives

On completion of this course delegates will know and understand:

  • The origin and reasons for GMP legislation
  • Key EU, UK and US GMP legislation
  • The practical interpretation of GMP expectations and best practices
  • EudraLex and PIC/S expectations
  • Premises, processes, products, procedures, people and GMP

Course Outline

  • Why we have pharmaceutical good manufacturing practices
  • EudraLex Volume 4
    • Structure
    • Content
    • Application

A copy of EudraLex Volume 4 is provided and is used as the basis of this course.

  • Where GMP fits in the lifecycle of a medicinal product
  • An understanding of global GMP requirements for pharmaceutical dosage forms
  • Up-to-the-minute information on new pharmaceutical good manufacturing practices initiatives and regulations
    • Changes to EU GMP regulation
  • Operating an effective PQS
  • Data integrity
  • Supply chain management
  • ICH Q9: Quality Risk Management
  • Practical advice on dealing with the “difficult areas” of pharmaceutical good manufacturing practices
    • Change control
    • Deviations
    • Assessing the effectiveness of training
  • An understanding of how pharmaceutical GMP is influenced by…
    • Premises
    • Processes
    • Products
    • Procedures
    • People
  • An appreciation of the critical GMP issues for…
    • Solid dosage forms
    • Sterile products
    • Liquids/semi-solids
    • Packing operations
    • Managing supply chains
  • Access to experts for opinion on your GMP concerns

We provide an optional post-course assessment that verifies proficiency of all course attendees.

Course Tutors

Course tutors will be selected from the following:

Samantha Clack - A working QP, lead auditor and QP trainee coordinator, Samantha has an up-to-date knowledge of GMP requirements and hands-on experience of how to implement and meet regulatory expectations.

Mike Halliday - Mike has over 30 years’ GMP experience covering every major dosage form.

Liz Allanson - As an ex UK MHRA inspector Liz has many years of international GMP auditing experience.

David Waddington - David has broad experience in QA and manufacturing management working with a wide range of different dosage forms for global supply including solids, liquids, sterile products, food supplements and natural products.

Other Dates and Venues for this Course

For other dates and venues for this course, visit our course calendar

Course Fees

Course cost (excluding VAT)  £2,370.00

DISCOUNTS AVAILABLE

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
charities and some self-funding individuals – contact us for details

Have a question or want to book a place? Contact pharmacourses@nsf.org - you can also register online by clicking below.

Register